FDA EIR - Pingdingshan Tianjing Plant Albumen Co., Ltd. - August 17, 2023

An FDA inspection of Pingdingshan Tianjing Plant Albumen Co., Ltd., a human food manufacturer in Pingdingshan, China, was conducted from August 15-17, 2023. The inspection, focusing on ready-to-eat soy protein powder and adherence to 21 CFR Part 117 (Preventive Controls for Human Food), revealed several significant issues. The firm received an FDA-483 for critical observations, including inadequate written sanitation preventive control procedures, evidenced by visible food residue and lack of chemical sanitizers on food contact surfaces. Environmental monitoring procedures were found deficient, lacking analytical methods and proper corrective actions. A severe issue was the company's provision of false Certificates of Analysis (COAs) to USA customers for multiple soy protein isolate shipments, claiming negative results for Salmonella and E. coli without supporting original test data. Additionally, the firm refused inspection access to their packaging room on two separate days. Facility issues included a dirty well water tank with condensate dripping, a submerged water hose without backflow prevention, poorly maintained exterior grounds creating pest harborage, and observable live and dead insects inside the production area. The assigned Preventive Controls Qualified Individual (PCQI) also lacked documented training. Management committed to voluntary corrective actions and is required to submit a written response to the FDA within 15 business days. Failure to comply could lead to further regulatory action.